The National Institute on Aging (NIA) invites applications
from qualified institutions for support of Alzheimer's Disease Research
Centers (ADRCs). These centers are designed to support and conduct
research on Alzheimer's disease (AD), to serve as shared research resources that
will facilitate research in AD and related disorders, distinguish them from
the processes of normal brain aging and mild cognitive impairment (MCI),
provide a platform for training, collect biospecimens useful for clinical
research, develop novel techniques and methodologies, and translate these
research findings into better diagnostic, prevention, treatment and care strategies.

Key Dates

Posted Date

March 1, 2013

Open Date (Earliest Submission Date)

May 10, 2013

Letter of Intent Due Date(s)

May 10, 2013

Application Due Date(s)

June 11, 2013, by 5:00 PM local time of applicant
organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October 2013

Advisory Council Review

January 2014

Earliest Start Date

March 2014

Expiration Date

June 12, 2013

Due Dates for E.O. 12372

Not Applicable

**ASSIST – electronic application submission required**

This FOA uses NIH’s new Application Submission System &
Interface for Submission Tracking (ASSIST) for the electronic preparation and
submission of multi-project applications through Grants.gov to NIH.
Applications to this FOA must be submitted electronically; paper applications
will not be accepted. ASSIST replaces the Grants.gov downloadable forms
currently used with most NIH opportunities and provides many features to enable
electronic multi-project application submission and improve data quality,
including: pre-population of organization and PD/PI data, pre-submission
validation of many agency business rules and the generation of data summaries
in the application image used for review.

Required Application Instructions

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed to do otherwise (in
this FOA or in a Notice from the NIH Guide for Grants and Contracts)
and where instructions in the Application Guide are directly related to the
Grants.gov downloadable forms currently used with most NIH opportunities.
Conformance to all requirements (both in the Application Guide and the FOA)
is required and strictly enforced. Applicants must read and follow all
application instructions in the Application Guide as well as any
program-specific instructions noted in Section
IV. When the program-specific instructions deviate from those in the
Application Guide, follow the program-specific instructions. Applications that
do not comply with these instructions may be delayed or not accepted for review.

Alzheimer's disease (AD) is
estimated to affect millions of older people in the United States.
Although it is occasionally identified in patients in their forties and
fifties, it is most frequently associated with advancing age. AD is the
most frequent cause of institutionalization for long-term care. It
destroys the active, productive life of its victims and devastates their
families financially and emotionally. It has been estimated that the United
States spends well over 100 billion dollars/year for the direct and indirect
costs of care for people with AD. The risk of AD increases greatly with
age, and projections suggest that the numbers of people with AD will increase
with the aging of the population unless effective interventions are found.

In the United States, the Executive and Legislative Branches
of the Federal Government have both expressed concern about the enormity of the
problem posed by AD, and in 2011, Congress passed the National Alzheimer’s
Project Act (NAPA). Congressional concern has focused on funding for
research on the causes, diagnosis, treatment, and prevention of the disease, as
well as on disparities and on the cost and coordination of care. In 1984,
Congress directed the National Institutes of Health (NIH), and in particular
the National Institute on Aging (NIA), to foster further research related to
AD. The NIA Alzheimer's Disease Centers (ADCs) program is authorized by
the Public Health Service Act, Section 445, and currently includes fifteen
Alzheimer's Disease Research Centers (ADRCs) and twelve Alzheimer's Disease
Core Centers (ADCCs).

The ADC program is moving into a new era, preparing to
capitalize on the extraordinary opportunities presented by leveraging the
strengths of the network of centers to provide large numbers of samples and
standardized clinical data collection from well-characterized participants as
well as a large pool of potential participants for future AD-related research.
At the same time, strong emphasis is placed on the unique contributions and new
directions of each individual center. Additionally, renewed emphasis is placed
on possibilities for utilizing the resources within and across the ADCs to
advance and augment the fields of drug discovery and drug development for novel
therapeutics for AD.

The principal aim of the ADRCs should be to enhance the
performance of innovative research on AD and related topics, including research
that may lead to potential disease-modifying therapy or behavioral or other
symptom treatments. Centers are requested to concentrate their attention
on better defining normal aging and the transition from normal aging to mild
cognitive impairment (MCI) to the earliest stages of dementia, whether AD
itself or other related dementias associated with aging. Clinical and
pathological information about the earliest cognitive changes is now beginning
to make it possible to develop strategies to prevent the disease from
developing or slow its progression. Attention should also be paid to
mixed dementias and overlapping neurodegenerative syndromes that often occur
with AD, such as vascular dementia, Lewy Body disease, Frontotemporal degeneration
and Parkinson’s dementia, in order to better differentiate among them and to
recognize commonalities. In addition, co-occurring conditions in other organ
systems that may contribute to clinical dementia could be studied.

Centers are expected to provide an environment and core
resources which will enhance cutting-edge research by bringing together
biomedical, behavioral, and clinical investigators to study the etiology,
pathogenesis, diagnosis, treatment, and prevention of AD, and to improve health
care delivery. Centers should also foster the development of new lines of
research and provide a rich training environment for fellows and junior faculty
to acquire research skills and experience in interdisciplinary AD
research. The Centers provide investigators and research groups with
well-characterized patients and control subjects, family information, and brain
tissue and biological specimens. Centers should incorporate contemporary
biochemical/molecular techniques and pursue research, when feasible, in
genomics, epigenomics, proteomics and metabolomics. Centers are
encouraged to develop in accordance with local talents, interests, and
resources, but should also be responsive to national needs related to AD.

The ADCs provide a mechanism for fostering and coordinating
the interdisciplinary cooperation of a group of established investigators
conducting programs of research on AD and related dementing disorders of older
people. The central focus may be translational research, clinical –
pathological research, basic research or a combination. Applicants are strongly
encouraged to include efforts to address the needs of, and research on,
ethnically and racially diverse people as well as other underserved
populations.

As part of a network, centers should be poised to
participate in cooperative efforts on a massive scale within a relatively short
time frame. Applicants must agree to collect a standard clinical data set (the
Uniform Data Set, or UDS) that is common to all Centers and will be transmitted
to the National Alzheimer’s Coordinating Center (NACC). To support the unique
research needs of the center, most centers collect additional data to
supplement those required by the UDS. Centers should demonstrate a
readiness to provide biological samples and data, with proper consent from well
characterized populations, to enable participation in large scale collaborative
national or international research projects.

Centers should work together with other AD research groups
in collaborative research activities and cooperate with other Federal, State,
and Local agency-supported AD programs (such as the Alzheimer's Disease
Cooperative Study (ADCS) and the Alzheimer's Disease Neuroimaging Initiative
(ADNI)), as well as the Alzheimer’s Association in furthering mutual
goals. Centers should also, whenever possible, cooperate with other NIA
Centers such as Pepper, Shock, and RCMAR Centers, and Udall Centers sponsored
by the National Institute of Neurological Disorders and Stroke (NINDS).

Other cores can be proposed if they contribute to the
overall mission of the Center, are scientifically justified, support projects
affiliated with the Center, and fit within the budget guidelines

ADRC applications will include, in addition, two or three
research projects with a duration of up to five years (equivalent to small R01
grants) at least one of which should depend on Clinical or Neuropathology Core
resources at the home Center or another Center. The number of research projects
funded and their duration will depend upon scientific quality. Funding for one
to three smaller one year pilot grants should also be requested. Centers should
show plans of career progression for junior investigators including leadership
of projects and cores within the center and successful pursuit of independent
funding.

The Center Grant may incorporate ancillary activities such
as longitudinal studies and limited patient care necessary to support the
primary research effort. The spectrum of activities should comprise a
multi-disciplinary approach to the problem of AD and other neurodegenerative
diseases, including distinguishing early stages from normal aging,
investigating mixed dementias, as well as studying unique aspects and subtypes
of these very complex and heterogeneous disease processes.

Section II. Award Information

Funding Instrument

Grant: A support mechanism providing money, property, or
both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Renewal

The OER
Glossary and the SF424 (R&R) Application Guide provide details on
these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations
and the submission of a sufficient number of meritorious applications.

The NIA intends to commit approximately $10 million
(total costs) in FY 2013 to fund 4-6 new and/or renewal grants in response to
this FOA.

Award Budget

New applications should request a project period of five
years and a budget for direct costs of up to $1 million per year.

Renewal applications may request direct costs for all
cores (both required and optional), and the other listed functions, i.e.,
projects, satellites, and pilot grants at a level not exceeding the combined
direct costs of all funded activities awarded during the final year of the
present funding period plus a 3% increase, or $1 million per year, whichever
is larger.

Award Project Period

5 years

NIH grants policies as
described in the NIH Grants
Policy Statement will apply to the
applications submitted and awards made in response to this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:

Eligible institutions should support an ongoing base of
high-quality AD research or research in other neurodegenerative diseases, or in
aging of the nervous system. To be eligible, an institution must support:

at least five Program Director(s)/Principal Investigator(s) with
any PHS agency (or comparable peer-reviewed federal, state, or foundation)
funded research grants related to AD, neurodegenerative diseases or aging of
the nervous system and each with at least two years of support remaining at the
time of application; or

one or more program project grants (P01s) related to AD, neurodegenerative
diseases or aging of the nervous system and with at least two years of support
remaining at the time of application.

The work that you propose in the ADC should be different
from the ongoing supported research. NIA will review overlap of existing
support through P01s or other award mechanisms and adjust support of the center
appropriately prior to any award. Your institution can have only one active
Alzheimer’s Center receiving NIA support.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Applicant organizations must complete the following registrations
as described in the SF424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
registrations.

System for
Award Management (SAM) – must maintain an active entity registration
(formerly CCR registration), to be renewed at least annually. Use the SAM.gov
“Manage Entity” function to manage your entity registrations. See the Grants
Registration User Guide at SAM.gov for additional information.

All Program Directors/Principal Investigators (PD(s)/PI(s)) and
component Project Leads that are not yet registered in eRA Commons must work
with their institutional officials to register. Also, institutional officials
at the applicant organization should ensure that the eRA Commons account for
the contact PD/PI is affiliated with their organization.

eRA Commons accounts are necessary to use ASSIST to prepare and submit
applications.

All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least 6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal
Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

The PD/PI should be a scientific leader experienced in the
field of AD and/or other neurodegenerative disease research and must be able to
coordinate, integrate, and provide guidance in the establishment of programs in
AD research and allied areas. A significant time commitment (2.4 person
months) must be made by the PD/PI.

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

NIH will not accept any application that is essentially the
same as one already reviewed within the past thirty-seven months (as described
in the NIH
Grants Policy Statement), except for submission:

To an RFA of an application that was submitted previously as an
investigator-initiated application but not paid;

Of an investigator-initiated application that was originally
submitted to an RFA but not paid; or

Of an application with a changed grant activity code.

Section IV. Application and Submission Information

1. Requesting an
Application Package

Applicants can access the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

Applicants will use NIH’s ASSIST system, rather than
Grants.gov’s downloadable forms, to prepare and submit applications through
Grants.gov to NIH.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise and where instructions in the
Application Guide are directly related to the Grants.gov downloadable forms
currently used with most NIH opportunities. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.

By the date listed in Part 1. Overview
Information, prospective applicants are asked to submit a letter of intent
that includes the following information:

Applications submitted to this FOA will be made up of a
collection of application components. All applications will include an
‘Overall’ component that provides information regarding the application as a
whole, as well as a combination of additional component types. Applicants should
select the appropriate application component types in ASSIST when preparing
applications. Note, eRA Commons accounts are necessary to use ASSIST to prepare
and submit applications.

Page Limitations

Component
Types Available in ASSIST

Research
Strategy/Program Plan Page Limits

Overall

12

Admin Core (Use this component for the Administrative
Core)

12

Cores (Use this component for each Required and Optional Core)

12

Project (Use this component for each Research Project)

12

Additional page limits described in the SF424 Application
Guide and the Table of
Page Limits must be followed.

Instructions for the Submission of Multi-Component
Applications

The following section supplements the instructions found in
the SF 424 Application Guide, and should be used for preparing a
multi-component application.

The application should consist of the following components:

Overall: required

Administrative Core: required

Clinical Core: required

Data Management and Statistical Core: required

Neuropathology Core: required

Outreach, Recruitment and Education Core: required

Satellite Diagnostic and treatment Clinics Cores: optional

Additional Cores: optional

Research Projects: 2 - 3 required

Cores and Projects will be listed in the order in which they
are entered into ASSIST. Please enter in ASSIST using the order listed above.

Overall Component

When preparing your application in ASSIST, use Component
Type ‘Overall’.

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell lines from other
components should be repeated in cell line table in Overall component.

Research & Related Other Project
Information (Overall)

Follow standard instructions.

Facilities
and Other Resources: Shared resources across cores should be
described in the Facilities and Other Resources attachment. Information from
this attachment will be used to evaluate the quality of the scientific
environment for the research proposed.

Project/Performance Site Location(s)
(Overall)

Enter primary site only.

A
summary of Project/Performance Sites in the Overall section of the assembled
application image in eRA Commons compiled from data collected in the other
components will be generated upon submission.

Research & Related Senior/Key
Person Profile (Overall)

Include only the Project Director/Principal
Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the
entire application.

A
summary of Senior/Key Persons followed by their Biographical Sketches in the
Overall section of the assembled application image in eRA Commons will be
generated upon submission.

ASSIST only allows a single biosketch for each
person. Therefore the biosketches must be comprehensive, covering multiple
roles if a single individual has multiple roles.

Program Director/Principal Investigator: The PD/PI
should be a scientific leader experienced in the field of AD and/or other
neurodegenerative disease research and must be able to coordinate, integrate,
and provide guidance in the establishment of programs in AD research and allied
areas.

An Alzheimer's Disease Research Center (ADRC) will be
an identifiable organizational unit formed by a single institution or a
consortium of cooperating institutions. Therefore, lines of authority
must be clearly specified. Each applicant institution will name an ADRC Director
(PD/PI) who will be the key figure in the administration, management and
coordination of the ADRC grant. The Director will be responsible for the
organization and operation of the ADRC.

Budget (Overall)

The only budget information included in the Overall
component is the Estimated Project Funding section of the SF424 (R&R)
Cover.

A
budget summary in the Overall section of the assembled application image in eRA
Commons compiled from detailed budget data collected in the other components
will be generated upon submission.

PHS 398 Research Plan
(Overall)

Specific
Aims: Describe the aims of the overall center and outline how
the different cores will contribute to these aims.

Research
Strategy:

Significance: Focusing on the center as a whole address
(i) the importance of the problem or critical barrier to progress in the field
that the proposed center is focused on, (ii) how the resources of the proposed
center will improve scientific knowledge, technical capability, and/or clinical
practice, (iii) how the concepts methods, technologies, treatments, services,
or preventive interventions that drive this field will be changed if the
proposed aims are achieved.

Enhance
the performance of innovative research on AD and related topics

Contribute
to the national network of Alzheimer’s Centers

Provide
an environment and resources to enhance cutting edge research by bringing
together investigators form various fields to study the etiology, pathogenesis,
diagnosis, treatment and prevention of AD

Advance
and augment the fields of drug discovery and drug development for novel therapeutics
for AD or other neurodegenerative diseases

Renewal Applications: Describe any changes in
research emphasis.

Innovation: Considering the center as a whole, show
how the proposed research seeks to shift current research or clinical practice
paradigms through use of novel concepts, approaches, methodologies,
instrumentation, or interventions. Does the proposed work refine, or improve,
or apply in a new way, the concepts, approaches, methodologies,
instrumentation, or interventions proposed?

Approach: Include the major approaches and studies in
the application showing how the approaches of cores complement each other or
are inter-dependent. Describe the mechanisms that will ensure the coherence of
the center and maintain a multidisciplinary focus.

Renewal Applications: Provide an Overall Progress
Report that addresses the major scientific achievements in research on AD,
normal aging and related topics carried out by Center personnel as well as by
research utilizing Center resources in the last funding period. Identify the
most significant findings that were facilitated or supported directly through
Center resources. Include summaries of progress in achieving the major aims of
the Center and highlight major publications. Provide examples of how the
presence of the ADC has brought new investigators into the field and has
stimulated non-ADC funded research in the last funding period. Explain the
Center’s role in generating new funding from grants as well as leveraging funds
from donors and other private sources. If referencing information
provided in particular cores within the application, include specific page
numbers to help reviewers find the appropriate information. Discuss the
interrelationship of the center to other activities in the applicant's
institution (e.g., other relevant research projects) and the extent of
institutional, departmental, and interdepartmental cooperation (charts and
tables may be included). In addition, describe the administrative relationships
of the proposed ADC to the institution. Include relevant issues relating to
institutional commitment and settings. May also present summary tables such as
those provided in the annual progress reports detailing: Federally and
non-federally funded grants that utilized resources from the Center, funding
for therapeutic trials and other grants from industry, collaborations
(including NACC, Alzheimer’s Association and others), and minority related
grants.

In lieu of a progress report, new applications will
be evaluated based on preliminary organizational work, experience with AD and
other neurodegenerative disease research, potential for developing new and
exciting research, and specific plans for implementation of the new
program.

Protection
of Human Subjects:

Describe the procedures for obtaining informed
consent for 1) research on cognitively impaired human subjects who may not have
the capacity to consent, specifically how proxy or surrogate consent will be obtained
in the context of local and state law 2) future participation in research
studies if the patient becomes unable to consent (advanced directive for
research) 3) placing data in the National Alzheimer’s Coordinating Center’s
Uniform Data Set and sharing data and specimens with other qualified scientists
consistent with achieving the goals of this program, and 4) autopsy, specifying
how and by whom and with whom the topic will be discussed, when and how
often. Attach samples of information given to patients and families and
copies of all consent forms. Attention should be paid to obtaining
advanced directives for research, and obtaining autopsy permission from
patients and families and informed consent for current and future use of
biological samples by qualified investigators. Permission should be obtained
for sharing of cells, DNA, and genetic and phenotypic information as well as
for storage in repositories. See the Biospecimen Task Force guidelines on the
NACC web site for further guidance on consent forms, as well as http://www.nia.nih.gov/research/dn/sharing-policy-and-guidance-research-genetics-alzheimers-disease for sample language regarding genetics that may be used in consent forms. Also,
if genome wide association studies (GWAS) are planned, applicants are expected
to follow the NIH policy on GWAS, available at: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html.

Inclusion
of Women and Minorities:

Describe the composition of the human subjects and the proactive
plan to recruit women, minorities,

List the page numbers for the relevant Women and Minorities
sections.

Inclusion
of Children:

Describe the composition of the human subjects and the proactive
plan to recruit children (if applicable).

For most NIA applications involving human participants, a
justifiable exclusion for children is that the topic is not relevant to
children.

Vertebrate
Animals:

Describe the general principles and policies that will apply to
vertebrate animals.

List the components in the application that involve vertebrate
animals and page numbers for the relevant Vertebrate Animal sections.

Consortium/Contractual
Arrangements

For consortium arrangements, the application must
include the following information:

An explanation of the programmatic, fiscal, and administrative
arrangements made between the grantee institution and the collaborating
institutions.

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424
(R&R) Application Guide, with the following modifications:

Applicants should commit to cooperate fully and to share
specimens with other research scientists both within and outside the Centers
network as well as data concerning clinical core participants with the
NIA-sponsored National Alzheimer’s Coordinating Center (NACC) where uniform
data from all AD Centers is centrally stored. Any genetic specimens collected
by the Center (blood samples and DNA) should be made available to the National
Cell Repository for Alzheimer’s Disease (NCRAD), if they meet the criteria for
inclusion in the repository, in accordance with agreed upon protocols and
policies. Centers may also be requested to contribute other biological
samples such as serum and cerebrospinal fluid, using agreed upon protocols, for
trans-center studies examining biomarkers that might relate to risk, diagnosis
or progression of AD. Therefore, consent forms should be written to allow for
this possibility as well as for the possibility of eventual data sharing with
the wider research community, while maintaining participants’ confidentiality. The
Steering Committee of the NACC in conjunction with the ADC Directors and the
NIA sets policies that allow the individual Centers to conduct research on
patients and control subjects collected by the individual Center while also
sharing common data sets with NACC. Applicants should follow NIA and NIH
policies on data and sample sharing (please see the following web pages for
further information, including example language that may be used in consent
forms:

Facilities
and Other Resources: Provide a description of all resources for
all proposed cores and projects in the Facilities and Other Resources
attachment. The information will be used to evaluate the quality of the
overall environment for the Center.

Project /Performance Site Location(s)
(Administrative Core)

List all performance sites that apply to the specific
component.

Note: The Project Performance Site form allows up to
300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key
Person Profile (Administrative Core)

In the Project Director/Principal Investigator section, use
Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA
Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list Senior/Key
persons that are working in the component.

Include a single Biographical Sketch for each Senior/Key person
listed in the application regardless of the number of components in which they
participate. When a Senior/Key person is listed in multiple components, the
Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component,
the Additional Senior Key Person attachments should be used.

ASSIST only allows a single biosketch for each person. Therefore
the biosketches must be comprehensive, covering multiple roles if a single
individual has multiple roles.

Core Project Leads should have demonstrated leadership and
administrative skills. Specifically, the Core Project Lead should be able to
organize and administer the resources created by the core or project in such a
way that they may be shared within the ADRC as well as with other interested
scientists. Demonstrated leadership in training young investigators is
desirable. The PD/PI of the ADRC may be a Core Project Lead, but sufficient
time must be devoted to the core or project to ensure that the aims are met and
required functions are carried out efficiently.

The Program Director/Principal Investigator of the proposed ADRC
should also be the Administrative Core Project Lead. The PD/PI’s biographical
sketch should present evidence of scientific expertise relevant to the themes
of the ADRC and demonstrate the capacity for the leadership of an ADRC. The
administrative requirements of the ADRC will necessitate the assistance of an
administrator with business management expertise. It is important that
such an individual be identified and be directly involved with the fiscal and
administrative aspects of the ADRC application and grant. The
administrator must be able to provide consultation in matters of fiscal
administration and be familiar with NIH grant-related compliance policies.

An Associate Director may be named who will be involved in the
administrative and scientific efforts of the Center

Budget (Administrative Core)

Budget forms appropriate for the specific component
will be included in the application package.

Note:
The R&R Budget form included in many of the component types allows for up
to 100 Senior/Key Persons in section A and 100 Equipment Items in section C
prior to using attachments for additional entries. All other SF424 (R&R)
instructions apply.

A detailed composite budget (across all subprojects
and cores) for all requested support categories for the proposed award period
will be system-generated based on budget period data. If applicable, use SF424 R&R
Subaward Budget Attachment Forms for consortium/contractual arrangements.
Provide one budget for each consortium grantee. If more than 30 subawardees,
then include details for additional subawardees in budget justification
(Section K). Any questions about budget development may be directed to the
Financial and Grants Management Contact listed below (Section VII).

All ADRC applications should request and provide
justification for five years of support in a single document in Section K of SF424
R&R Budget Form. The direct costs may be apportioned across cores and
pilots at the PD/PI discretion in order to best serve the unique needs of the
center. If large items of equipment are requested, the application must
document what is already available and provide clear justification in terms of
use by core staff and how it relates to research projects dependent on the
core. General-purpose equipment needs should be included and justified
only after surveying the availability of such items within the institution. See
Section C of SF424 R&R Budget Form.

Research patient care costs (both inpatient and
outpatient expenses) will be considered in the context of other existing
institutional clinical resources. Attempts should be made by the applicant
institution to utilize existing clinical facilities. Costs relating to
the clinical efforts of the ADRC may be funded through the ADRC, provided there
is no overlap of funding. Only those research patient costs directly related to
ADRC activities may be charged to the ADRC. See Special Instructions for
Patient Care Costs in SF424 (R&R) Application Guide.

Domestic and foreign travel of project personnel
directly related to the core and scientific activities of the ADRC is
allowable. Budgeting should include travel and lodging for 1) the
semi-annual meetings of the Center Directors, 2) annual meetings of
administrators, clinical core leaders, education core leaders, data managers,
and neuropathology core leaders and, 3) representatives of the Center to attend
ad hoc meetings called by the ADCs or the NIA to discuss research findings and
plan cooperative projects, to promulgate data sharing, and to discuss
standardization of procedures among the ADCs. See Section D of SF424 R&R
Budget Form.

Requests for pilots in competing applications (new
and renewal) will be budgeted in the Administrative Core budget. A brief
description of the first year pilot research and detailed pilot budgets for the
first year of Center funding will be requested as Just-in-Time information through eRA Commons shortly before the award of successful applications, and
future year pilots should be submitted with the annual non-competing renewal
applications. Facilities & Administrative costs will be provided in
accordance with these budgets.

Pilot costs should be in the range of $25,000-$35,000
direct costs per year. Pilot projects may be awarded to investigators outside
of the home institution. Funds for the pilot projects should be included under
the other expenses within the administrative core budgets. These funds
should not be listed as a separate line in the composite budget. Pilot grants
are allowed for consortium arrangements.

Include funds for travel of the PD/PI and other key
personnel 1) to the semiannual meetings of the Center Directors, 2) for at
least 2 ad hoc meetings on special topics, 3) for visits of Center
investigators to other ADCs for the exchange of scientific ideas, planning of
multi Center research projects and to receive training in specialized
techniques, 4) for the Administrator to attend the Administrators’ meeting and
5) for core leaders to attend meetings with core leaders from other ADCs.

PHS 398 Research Plan (Administrative
Core)

A core is a shared central laboratory or clinical
research facility, service, or resource whose function is essential to the
scientific purpose of the ADC. Each core is directed by an investigator
with substantial expertise related to the core. Facilities may be proposed that
will enhance productivity or in other ways benefit a group of investigators to
accomplish stated goals. Several important and related
considerations are (1) the degree to which currently funded investigators
within or outside the Center will use and will benefit from core resources, (2)
the degree to which the cores coordinate with each other to further the overall
Center mission and (3) the degree to which the resources will promote new and/or
expanded AD research efforts locally, regionally or nationally.
Applicants should document and describe briefly the research, both existing and
planned, whether funded by the Center or not, that has, or will depend upon,
resources provided by the requested cores.

Specific
Aims: Clearly state how the core will contribute to the goals
of the ADC and outline interactions of the core with each of the other cores
and projects of the center. Provide an overview of how the core will set the
overall direction of the Center and ensure optimal utilization of Center
resources.

Research
Strategy: Organize the Research Strategy into sections on:
Significance, Innovation and Approach.

Significance: Explain the role of the Administrative core in the center as a whole and as a
resource for other ongoing activities in Alzheimer’s disease and other
neurodegenerative diseases.

Approach:

Progress Report (Renewal Applications only): Provide
evidence of successful overall integration of cores to promote the theme(s) of
the center as well as interaction within the academic and local and national
communities. Provide evidence of productivity of funded pilot grants. Describe
the most important contributions to research on AD, related dementias and aging
utilizing core resources. Reports should include Core objectives and
progress in meeting them. Basic functions of the cores should be briefly
summarized. Any developmental work carried out by the core should also be
presented. Publications resulting from resources or developmental work carried
out by the core should be listed.

New applications should describe preliminary
organizational work, experience with AD and other neurodegenerative disease
research, potential for developing new and exciting research, and specific plans
for implementation of the new program.

Describe how the center's administrative structure will
facilitate the following:

coordination
and integration of Center components and activities; (for example, the clinical
and data management cores with the neuropathology and education components)

direction
for future planning and optimal utilization of resources

support
and advice for the Center Director in his/her oversight of the activities of
the Center

interaction
with the scientific and lay communities to develop relevant goals for the Center

coordination
and organization of external and internal advisory committee meetings

coordination
and organization of pilot project advertisement, review, and submission of
pilot projects to NIA for approval

An
External Advisory Committee (EAC) to annually evaluate the programs of the ADC,
research progress, the effectiveness of communications within the ADC,
interactions with NACC, and any other activities for which outside expertise is
required or desirable. EAC members should not be named in the application and
should not be contacted for participation in the committee prior to award. A
member of the NIA extramural program staff should be invited to attend EAC
meetings. A copy of the advisory committee report should be routinely sent to
the NIA with the annual progress report and should include a list of committee
members after they have been appointed.

An
executive committee (composed of core project leads and the administrator) to
assist the Director in making the scientific and administrative decisions
relating to the Center utilizing advice and consultation, both from within the
institution and from other institutions, to monitor and develop the scientific
content and direction of the center;

A review
panel to assist in selecting pilot projects. Criteria for selecting committee
members, how they will be identified, the operating procedures of the groups
and the frequency of meetings should be described. Review should include a
biostatistician as well as scientists from outside the Center. New applications
should not select committee members prior to peer review of the Center
application. Members from the External Advisory Committee may serve as
reviewers for the pilot applications, provided their expertise is appropriate
for the submitted applications.

Pilot Projects: A plan to support one to three pilot projects
for basic or clinical biomedical, translational, and epidemiological, caregiving,
educational or behavioral research should be included and budgeted in the
application. The announcement for pilot funding should include a description of
data available through NACC, including their website. Use of this resource
should be strongly encouraged. This funding mechanism is intended to allow an
investigator the opportunity to develop preliminary data sufficient to provide
the basis for an application for independent research support. They are
designed for postdoctoral or junior faculty level investigators, but may be
awarded to a more senior investigator who has experience in areas other than AD
research, and who wants to work in the AD research field or who wants to try a
new hypothesis, method, or approach that is not an extension of ongoing AD
research. Any one investigator is eligible only once for pilot support, unless
the additional proposed pilot project constitutes a real departure from his or
her ongoing research. Pilot projects are typically limited to a
nonrenewable single year of support. If described and well justified, two
years of support may be requested.

Examples of possible pilot projects are:

A study
based on data in the NACC data set to determine the feasibility of conducting
larger studies in the future.

A study
proposed by a new investigator, with an interest in research in AD, before the
study has developed to the point of being suitable to apply for individual
grant support.

Functional,
mechanistic, or pre-clinical activities designed to move a basic discovery
towards a translational endpoint in the near future.

No pilot project applications should be submitted
with the Center application. Funds designated for pilots are restricted until
the pilots receive NIA approval. Successful Center applicants should conduct a
competition and submit the successful applications to NIA for the first year of
pilot funding after receiving notice of grant award; in subsequent years
competition for pilot awards should be timed so successful applications can be
submitted with the non-competing renewal application for NIA review.

Consortium/Contractual
Arrangements

For consortium arrangements, the application must
include the following information:

An explanation of the programmatic, fiscal, and administrative
arrangements made between the grantee institution and the collaborating
institutions.

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424
(R&R) Application Guide, with the following modifications:

Applicants should commit to cooperate fully and to share
specimens with other research scientists both within and outside the Centers
network as well as data concerning clinical core participants with the
NIA-sponsored National Alzheimer’s Coordinating Center (NACC) where uniform
data from all AD Centers is centrally stored. Any genetic specimens collected
by the Center (blood samples and DNA) should be made available to the National
Cell Repository for Alzheimer’s Disease (NCRAD), if they meet the criteria for
inclusion in the repository, in accordance with agreed upon protocols and policies.
Centers may also be requested to contribute other biological samples such as
serum and cerebrospinal fluid, using agreed upon protocols, for trans-center
studies examining biomarkers that might relate to risk, diagnosis or
progression of AD. Therefore, consent forms should be written to allow
for this possibility as well as for the possibility of eventual data sharing
with the wider research community, while maintaining participants’
confidentiality. The Steering Committee of the NACC in conjunction with the ADC
Directors and the NIA sets policies that allow the individual Centers to
conduct research on patients and control subjects collected by the individual
Center while also sharing common data sets with NACC. Applicants should follow
NIA and NIH policies on data and sample sharing (please see the following web
pages for further information, including example language that may be used in
consent forms:

Facilities
and Other Resources: Provide a description of all resources for
this core in the Facilities and Other Resources attachment. The information
will be used to evaluate the quality of the environment for this specific core.

Clinical cores of ADCs are usually based in
university medical center neurology or psychiatry department memory disorders
clinics, but they may also, or instead, include special populations that might
be available to some applicants such as an ethnic or minority population, a
religious community or a community population living in elderly housing where
the likelihood of being able to study the full spectrum from normal aging to
mild cognitive impairment to AD would be possible.

Project /Performance Site Location(s)
(Clinical Core)

List all performance sites that apply to the specific
component.

Note: The Project Performance Site form allows up to
300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key
Person Profile (Clinical Core)

In the Project Director/Principal Investigator section, use
Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA
Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list Senior/Key
persons that are working in the component.

Include a single Biographical Sketch for each Senior/Key person
listed in the application regardless of the number of components in which they
participate. When a Senior/Key person is listed in multiple components, the
Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component,
the Additional Senior Key Person attachments should be used.

ASSIST only allows a single biosketch for each person. Therefore
the biosketches must be comprehensive, covering multiple roles if a single
individual has multiple roles.

Core Project Leads should have demonstrated leadership and
administrative skills. Specifically, the Core Project Lead should be able to
organize and administer the resources created by the core or project in such a
way that they may be shared within the ADRC as well as with other interested
scientists. Demonstrated leadership in training young investigators is
desirable. The PD/PI of the ADRC may be a Core Project Lead, but sufficient
time must be devoted to the core or project to ensure that the aims are met and
required functions are carried out efficiently.

The Clinical Core Project Lead is often a neurologist, but may be
a neuropsychologist, psychiatrist, geriatrician or other clinician with
expertise in diagnosing Alzheimer’s and other neurodegenerative diseases. The
Clinical Core Project Lead should have a track record of research in some
aspect of neurodegenerative disease, preferably including interactions with key
personnel from other cores.

Budget (Clinical Core)

Budget forms appropriate for the specific component
will be included in the application package.

Note:
The R&R Budget form included in many of the component types allows for up
to 100 Senior/Key Persons in section A and 100 Equipment Items in section C
prior to using attachments for additional entries. All other SF424 (R&R)
instructions apply.

A detailed composite budget (across all subprojects
and cores) for all requested support categories for the proposed award period
will be system-generated based on budget period data. If applicable, use SF424 R&R
Subaward Budget Attachment Forms for consortium/contractual arrangements.
Provide one budget for each consortium grantee. If more than 30 subawardees,
then include details for additional subawardees in budget justification
(Section K). Any questions about budget development may be directed to the
Financial and Grants Management Contact at the address below (Section VII).

All ADRC applications should request and provide
justification for five years of support in a single document in Section K of SF424
R&R Budget Form. The direct costs may be apportioned across cores and pilots
at the PD/PI discretion in order to best serve the unique needs of the center.
If large items of equipment are requested, the application must document what
is already available and provide clear justification in terms of use by core
staff and how it relates to research projects dependent on the core.
General-purpose equipment needs should be included and justified only after
surveying the availability of such items within the institution. See Section C
of SF424 R&R Budget Form.

Research patient care costs (both inpatient and
outpatient expenses) will be considered in the context of other existing
institutional clinical resources. Attempts should be made by the applicant
institution to utilize existing clinical facilities. Costs relating to the
clinical efforts of the ADRC may be funded through the ADRC, provided there is
no overlap of funding. Only those research patient costs directly related to
ADRC activities may be charged to the ADRC. See Special Instructions for
Patient Care Costs in SF424 (R&R) Application Guide.

Domestic and foreign travel of project personnel
directly related to the core and scientific activities of the ADRC is
allowable. Budgeting should include travel and lodging for 1) the
semi-annual meetings of the Center Directors, 2) annual meetings of
administrators, clinical core leaders, education core leaders, data managers,
and neuropathology core leaders and, 3) representatives of the Center to attend
ad hoc meetings called by the ADCs or the NIA to discuss research findings and
plan cooperative projects, to promulgate data sharing, and to discuss
standardization of procedures among the ADCs. See Section D of SF424 R&R
Budget Form.

If an optional satellite core is included, it should
have a separate budget in a core component specific to the satellite core. If
an existing satellite has been rolled into a clinical core, the budget for the
satellite must still be identifiable within the budget justification of the clinical
core budget.

PHS 398 Research Plan (Clinical
Core)

A core is a shared central laboratory or clinical
research facility, service, or resource whose function is essential to the
scientific purpose of the ADC. Each core is directed by an investigator
with substantial expertise related to the core. Facilities may be proposed that
will enhance productivity or in other ways benefit a group of investigators to
accomplish stated goals. Several important and related
considerations are (1) the degree to which currently funded investigators
within or outside the Center will use and will benefit from core resources, (2)
the degree to which the cores coordinate with each other to further the overall
Center mission and (3) the degree to which the resources will promote new
and/or expanded AD research efforts locally, regionally or nationally.
Applicants should document and describe briefly the research, both existing and
planned, whether funded by the Center or not, that has, or will depend upon,
resources provided by the requested cores.

Specific
Aims: Clearly state how the core will contribute to the goals
of the ADC and outline interactions of the core with each of the other cores
(and projects, if relevant) of the center.

Describe the target population for which the core
will provide well-characterized, longitudinally followed patients and control
subjects for cutting edge research projects involving e.g., clinicopathological
correlations, comparison of disease states to normal aging (including those
using biological samples or imaging), and drug/intervention studies.

Research
Strategy: Organize the Research Strategy into sections on:
Significance, Innovation and Approach.

Significance: The clinical core has the responsibility of establishing and maintaining a
clinical enterprise that provides valuable, well-documented resources for
cutting edge clinical research for both center personnel and the wider
scientific community. Explain the role of the clinical core in the center as a
whole and as a resource for other ongoing activities in Alzheimer’s disease and
other neurodegenerative diseases. If the clinical core will include
special populations, the applicant must describe the characteristics of the
population and justify the added scientific value to research at the Center
resulting from the inclusion of this group, so that peer reviewers can evaluate
the comparative strengths and weaknesses of the proposed clinical core. If the
application includes a satellite clinic as part of the clinical core, explain
its significance.

Approach:

Progress Report (Renewal Applications only): Clearly
summarize resource use in affiliated research projects (both funded by the
center and externally funded) and the new insights obtained from these studies.
Describe demographic information including numbers and kinds of participants
recruited, diagnosis, percentage follow up and dropout rate and reasons for
drop out, and diagnostic accuracy confirmation by autopsy. Describe the most
important contributions to research on AD, related dementias and aging
utilizing core resources. Reports should include Core objectives and
progress in meeting them. Basic functions of the cores should be briefly
summarized. Any developmental work carried out by the core should also be
presented. Publications resulting from resources or developmental work carried
out by the core should be listed.

New applications should describe preliminary
organizational work, experience with AD and other neurodegenerative disease
research, potential for developing new and exciting research, and specific
plans for implementation of the new program.

The clinical core, in addition to patient and control
subject recruitment, provides evaluation, and diagnosis, maintains a patient
registry that tracks number and reasons for subjects lost to follow-up, and
conducts longitudinal follow up of patients and control subjects.
Procedures should be described related to collection, storage, and distribution
of biological samples, that may include, but are not limited to, cell lines,
cerebrospinal fluid (CSF), blood and plasma; particular attention should be
paid to an ability to share these samples both within and outside the Center as
well as best practices for collection and use of biospecimens detailed in
documents available on the NACC website at https://www.alz.washington.edu/BiospecimenTaskForce.html , as well as http://www.nia.nih.gov/research/dn/alzheimers-disease-genetics-sharing-plan

Recent developments in biomarker research and
improvements in evaluation of cognitive change in normal aging, and preclinical
stages of mild cognitive impairment (MCI) and AD, present new opportunities for
research on early stages of disease and diminish the necessity to enroll only
symptomatic subjects. In those Centers with research interests related to the
earliest stages of disease, Clinical Cores are encouraged to recruit
cognitively normal but higher risk subjects for natural history and biomarker
studies. Retention and follow-up are of critical importance for this group of
subjects just as for the regular Clinical Core subjects. Such subjects may be
selected for age, ApoE status, family history or any other criteria that may
predict higher risk of developing Alzheimer or neurodegenerative pathology.
These subjects would be very valuable for primary and secondary prevention
trials supported by other grants. Cognitively normal higher risk subjects
would receive the baseline clinical and psychometric evaluation for the UDS
that all subjects enrolled in the Clinical Core receive, and biospecimens would
be collected, but these subjects would not necessarily be seen for an in-person
UDS visit annually. Instead these cognitively normal subjects could be given a
brief UDS compatible telephone-based cognitive test(s) at their first and
second annual follow-up scheduled approximately one and two years after initial
enrollment. However, if a clinically important decline in cognition is noted
at one of the telephone follow-up calls, the subject would be scheduled for a
full, in-person clinical evaluation (including UDS) as soon as would be
feasible. From that point forward the subject would be seen annually for an in-person evaluation.
If cognitive or functional decline does not trigger an
in-person visit earlier, all subjects would be brought back to the ADRC for a
full evaluation in the third year after enrollment. In the cognitively normal
subjects it would be critically important to obtain serial biological fluid
biomarker measurements and, when possible, serial imaging following the
baseline enrollment visit. If the natural history of biomarker change and
correlation with clinical disease can become well established, such biomarkers
may eventually serve as intermediate endpoints for clinical trials or
intervention.

Longitudinal data on preclinical stages of AD, MCI,
possible and probable AD, other neurodegenerative disorders and normal aging
should be collected and transmitted in a timely manner to the Data Management
and Statistics core. Cooperation, concurrence and collaboration with the
Data Management and Statistics core should continue from the initial
specification of data content through data collection to database management
and data analysis. A clear linkage between clinical and neuropathological data
should be described. There should be a commitment to working across the center
to increase the number of participants who agree to autopsy, especially of
controls and persons with MCI or early in the course of AD. Applicants
must state in this section of the application that they agree to collect and
provide the Uniform Data Set (UDS) to NACC where it will be combined with data
from other Centers and made available to scientists for collaborative studies.
Participants should be enrolled in the clinical core with the intent of
longitudinal follow-up. Information on the UDS is available from NACC (https://www.alz.washington.edu/).

The clinical core may perform a limited amount of
developmental work, but should not directly support research per se. The
developmental work allowable in a clinical core must be related to the function
of the core. It may be directed toward improving and expanding the core
functions, e.g., improving existing diagnostic strategies, or developing
additional methodologies, techniques or services. Proposed developmental
work should be described in the application.

Include a description of the types (with specific
examples) of research projects and clinical trials that use or will use the
core and what benefits will obtain to other research activities from the
existence of the clinical core. While supporting clinical drug trials may be
one function of a clinical core, it should not be the only major effort of the
core.

Inclusion
of Women and Minorities

Summarize strategies, with reference to the education
core, to recruit and retain participants from diverse backgrounds including a
description of how the plan fits with all of the proposed research that will
make use of the core. The plan should demonstrate sensitivity to research
design and biostatistical analysis. Procedures for communicating recruitment
needs to the Education Core and for evaluating success should be outlined.

The inclusion of participants with different
characteristics will assist investigators in providing answers to questions
about AD diagnosis, treatment, and management strategies that are likely to be
applicable to the broad U.S. population. Additionally, a more diverse
participant pool will facilitate investigations of the neuropathology and
genetics of AD as well as studies of care giving and family burden in diverse
groups. Diversity of participants may be achieved in multiple ways. One option
is to have a Satellite Clinic in locations that have higher populations of
underserved individuals.

Consortium/Contractual
Arrangements

For consortium arrangements, the application must
include the following information:

An explanation of the programmatic, fiscal, and administrative
arrangements made between the grantee institution and the collaborating
institutions.

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424
(R&R) Application Guide, with the following modifications:

Applicants should commit to cooperate fully and to share
specimens with other research scientists both within and outside the Centers
network as well as data concerning clinical core participants with the
NIA-sponsored National Alzheimer’s Coordinating Center (NACC) where uniform
data from all AD Centers is centrally stored. Any genetic specimens collected
by the Center (blood samples and DNA) should be made available to the National
Cell Repository for Alzheimer’s Disease (NCRAD), if they meet the criteria for
inclusion in the repository, in accordance with agreed upon protocols and
policies. Centers may also be requested to contribute other biological
samples such as serum and cerebrospinal fluid, using agreed upon protocols, for
trans-center studies examining biomarkers that might relate to risk, diagnosis
or progression of AD. Therefore, consent forms should be written to allow
for this possibility as well as for the possibility of eventual data sharing
with the wider research community, while maintaining participants’
confidentiality. The Steering Committee of the NACC in conjunction with the ADC
Directors and the NIA sets policies that allow the individual Centers to
conduct research on patients and control subjects collected by the individual
Center while also sharing common data sets with NACC. Applicants should follow
NIA and NIH policies on data and sample sharing (please see the following web
pages for further information, including example language that may be used in
consent forms:

Facilities
and Other Resources: Provide a description of all resources for
this core in the Facilities and Other Resources attachment. The information
will be used to evaluate the quality of the environment for this specific core.

In the Project Director/Principal Investigator section, use Project
Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons
ID in the Credential field.

In the additional Senior/Key Profiles section, list Senior/Key
persons that are working in the component.

Include a single Biographical Sketch for each Senior/Key person
listed in the application regardless of the number of components in which they
participate. When a Senior/Key person is listed in multiple components, the
Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component,
the Additional Senior Key Person attachments should be used.

ASSIST only allows a single biosketch for each person. Therefore
the biosketches must be comprehensive, covering multiple roles if a single individual
has multiple roles.

Core Project Leads should have demonstrated leadership and
administrative skills. Specifically, the Core Project Lead should be able to
organize and administer the resources created by the core or project in such a
way that they may be shared within the ADRC as well as with other interested
scientists. Demonstrated leadership in training young investigators is
desirable. The PD/PI of the ADRC may be a Core Project Lead, but sufficient
time must be devoted to the core or project to ensure that the aims are met and
required functions are carried out efficiently.

This Core Project Lead's biosketch should reflect awareness of
and experience with database management practices, computing and statistics.
The Core Project Lead may be primarily a data manager or a statistician. The
Core Project Lead must have the time and the authority to work administratively
with other cores. The core should include a) a systems manager for
computing and database management who will be the architect of the database
structure and responsible for its maintenance, and b) a systems analyst with
sufficient background to select and implement database management software,
represent data structures, specify and organize data flow, construct detailed
“error-check” programs, develop/implement data checking and cleaning
procedures, and provide for data entry and access, as well as information
distribution, through electronic means (e.g., the internet or intranet), and c)
a statistician who can consult with researchers on design and analysis of their
projects, if the Core Project Lead is not a statistician.

Budget (Data Management and
Statistical Core)

Budget forms appropriate for the specific component
will be included in the application package.

Note:
The R&R Budget form included in many of the component types allows for up
to 100 Senior/Key Persons in section A and 100 Equipment Items in section C
prior to using attachments for additional entries. All other SF424 (R&R)
instructions apply.

A detailed composite budget (across all subprojects
and cores) for all requested support categories for the proposed award period
will be system-generated based on budget period data. If applicable, use SF424 R&R
Subaward Budget Attachment Forms for consortium/contractual arrangements.
Provide one budget for each consortium grantee. If more than 30 subawardees,
then include details for additional subawardees in budget justification
(Section K). Any questions about budget development may be directed to the
Financial and Grants Management Contact at the address below (Section VII).

All ADRC applications should request and provide
justification for five years of support in a single document in Section K of SF424
R&R Budget Form. The direct costs may be apportioned across cores and
pilots at the PD/PI discretion in order to best serve the unique needs of the
center. If large items of equipment are requested, the application must
document what is already available and provide clear justification in terms of
use by core staff and how it relates to research projects dependent on the
core. General-purpose equipment needs should be included and justified
only after surveying the availability of such items within the institution. See
Section C of SF424 R&R Budget Form.

Research patient care costs (both inpatient and
outpatient expenses) will be considered in the context of other existing
institutional clinical resources. Attempts should be made by the applicant
institution to utilize existing clinical facilities. Costs relating to
the clinical efforts of the ADRC may be funded through the ADRC, provided there
is no overlap of funding. Only those research patient costs directly related to
ADRC activities may be charged to the ADRC. See Special Instructions for
Patient Care Costs in SF424 (R&R) Application Guide.

Domestic and foreign travel of project personnel
directly related to the core and scientific activities of the ADRC is
allowable. Budgeting should include travel and lodging for 1) the
semi-annual meetings of the Center Directors, 2) annual meetings of
administrators, clinical core leaders, education core leaders, data managers,
and neuropathology core leaders and, 3) representatives of the Center to attend
ad hoc meetings called by the ADCs or the NIA to discuss research findings and
plan cooperative projects, to promulgate data sharing, and to discuss
standardization of procedures among the ADCs. See Section D of SF424 R&R
Budget Form.

PHS 398 Research Plan (Data
Management and Statistical Core)

A core is a shared central laboratory or clinical
research facility, service, or resource whose function is essential to the
scientific purpose of the ADC. Each core is directed by an investigator
with substantial expertise related to the core. Facilities may be proposed that
will enhance productivity or in other ways benefit a group of investigators to
accomplish stated goals. Several important and related
considerations are (1) the degree to which currently funded investigators
within or outside the Center will use and will benefit from core resources, (2)
the degree to which the cores coordinate with each other to further the overall
Center mission and (3) the degree to which the resources will promote new
and/or expanded AD research efforts locally, regionally or nationally. Applicants
should document and describe briefly the research, both existing and planned,
whether funded by the Center or not, that has, or will depend upon, resources
provided by the requested cores.

Specific
Aims: Clearly state how the core will contribute to the goals
of the ADC and outline interactions of the core with each of the other cores
(and projects, if relevant) of the center.

Describe both database and statistical services that
will be provided to the cores and pilots. Outline the process for contributing
data to NACC and for making data available both within and outside of the
center, consistent with achieving the goals of the program.

Research
Strategy: Organize the Research Strategy into sections on:
Significance, Innovation and Approach.

Significance: The Data Management and Statistics core both performs data management and
provides statistical consultation and liaison with other cores and projects.
Data cores are important to facilitate not only local analyses but also
collaborations between and among Centers and with NACC. Explain the role
of the Data Management and Statistics core in the center as a whole and as a
resource for other ongoing activities in Alzheimer’s disease and other
neurodegenerative diseases.

Approach:

Progress Report (Renewal Applications only):
Summarize progress and activities related to data collection, data management
and statistical consulting activities. Describe the most important
contributions to research on AD, related dementias and aging utilizing core
resources. Reports should include Core objectives and progress in meeting
them. Basic functions of the cores should be briefly summarized. Include
progress and interactions with NACC as well as descriptions of any novel data
analysis or study design strategies that have been developed. Present evidence
for meeting timetables for data transfer in the proper format to NACC. Any
developmental work carried out by the core should also be presented.
Publications resulting from resources or developmental work carried out by the
core should be listed.

New applications should describe preliminary
organizational work, experience with AD and other neurodegenerative disease
research, potential for developing new and exciting research, and specific
plans for implementation of the new program.

The data core should have the capacity to prepare the
Uniform Data Set (UDS) for transmission to the National Alzheimer's Disease
Coordinating Center (NACC) which in turn will make appropriate data sets
available to qualified investigators for further research. Any data sharing
plan that is approved will be part of the terms and conditions of the award. The
funding organization will be responsible for monitoring the data sharing
policy. The data core should be adequately funded and staffed to allow required
tasks to be carried out. (New applicants may contact NACC to learn more about
NACC procedures, the structure of the uniform data set, and the regular updates
to the datasets required from all Centers; http://www.alz.washington.edu/).

a
Center-wide system of subject ID numbers that meets privacy standards,

adequate
filing systems for raw data within the cores/projects and within the data core
itself,

a
mechanism to track data edits,

longitudinal
follow-up data storage/retrieval consistent with the protocols of the center.

The staff of the data core should work with clinical
and research personnel to transfer their data into computer usable form, as
well as with statisticians to insure that the data are represented in a fashion
that will allow the analyses to be accomplished. Data core staff should have a
working relationship with core data collectors and have their cooperation to
reconcile errors and missing or incomplete data elements as discovered through
error check programs or through ‘hands-on’ inspection procedures. In addition
the core staff should work cooperatively with the NACC staff and respond
appropriately to data calls issued by NACC.

Biostatistics consultation and liaison should:

be
involved in the design and analysis of studies using patient data and/or
biomaterials from the Cores

work
closely with the data manager to insure analysis files are produced that are
consistent with the needs of the question at hand

be
available for consultation with pilot project applicants and awardees as well
as with affiliated research project investigators.

Other possible functions of the core might include:

Manage
database issues related to scheduling and other participant tracking

Develop
improved mathematical models that might help e.g., identify mediation or
improve understanding of the interactions of multiple variables on cognitive
decline

Develop
enhanced statistical techniques to improve trial design with a focus on issues
relevant to detecting cognitive decline early in the disease process

Consortium/Contractual
Arrangements

For consortium arrangements, the application must
include the following information:

An explanation of the programmatic, fiscal, and administrative
arrangements made between the grantee institution and the collaborating
institutions.

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424
(R&R) Application Guide, with the following modifications:

Applicants should commit to cooperate fully and to share
specimens with other research scientists both within and outside the Centers
network as well as data concerning clinical core participants with the
NIA-sponsored National Alzheimer’s Coordinating Center (NACC) where uniform
data from all AD Centers is centrally stored. Any genetic specimens collected
by the Center (blood samples and DNA) should be made available to the National
Cell Repository for Alzheimer’s Disease (NCRAD), if they meet the criteria for
inclusion in the repository, in accordance with agreed upon protocols and
policies. Centers may also be requested to contribute other biological
samples such as serum and cerebrospinal fluid, using agreed upon protocols, for
trans-center studies examining biomarkers that might relate to risk, diagnosis
or progression of AD. Therefore, consent forms should be written to allow
for this possibility as well as for the possibility of eventual data sharing
with the wider research community, while maintaining participants’
confidentiality. The Steering Committee of the NACC in conjunction with the ADC
Directors and the NIA sets policies that allow the individual Centers to
conduct research on patients and control subjects collected by the individual
Center while also sharing common data sets with NACC. Applicants should follow
NIA and NIH policies on data and sample sharing (please see the following web
pages for further information, including example language that may be used in
consent forms:

Facilities
and Other Resources: Provide a description of all resources for
this core in the Facilities and Other Resources attachment. The information
will be used to evaluate the quality of the environment for this specific core.

Facilities and equipment for use in carrying out the
activities of the core should be described in this section. The procedure for
prioritizing the use of tissues and other biological samples stored at the
Center should be discussed along with a brief description of potential research
projects that will use the samples. Best practice guidelines for handling
biospecimens have been developed and are posted on the NACC website: https://www.alz.washington.edu/BiospecimenTaskForce.html.
Procedures to provide coded samples to investigators that protect the identity
of the patients should be described. Neuropathology cores should provide the
infrastructure necessary for applying novel technologies, techniques and/or
information to increase the value of stored tissues and fluids, especially
those that have longitudinal data available.

Project /Performance Site Location(s)
(Neuropathology Core)

List all performance sites that apply to the specific
component.

Note: The Project Performance Site form allows up to
300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key
Person Profile (Neuropathology Core)

In the Project Director/Principal Investigator section, use
Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA
Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list Senior/Key
persons that are working in the component.

Include a single Biographical Sketch for each Senior/Key person
listed in the application regardless of the number of components in which they
participate. When a Senior/Key person is listed in multiple components, the
Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component,
the Additional Senior Key Person attachments should be used.

ASSIST only allows a single biosketch for each person. Therefore
the biosketches must be comprehensive, covering multiple roles if a single
individual has multiple roles.

Core Project Leads should have demonstrated leadership and
administrative skills. Specifically, the Core Project Lead should be able to
organize and administer the resources created by the core or project in such a
way that they may be shared within the ADRC as well as with other interested
scientists. Demonstrated leadership in training young investigators is
desirable. The PD/PI of the ADRC may be a Core Project Lead, but sufficient
time must be devoted to the core or project to ensure that the aims are met and
required functions are carried out efficiently.

The Core Project Lead should have a track record of research in
some aspect of neurodegenerative disease, preferably including interactions
with key personnel from other cores. The Core Project Lead should have
demonstrated knowledge of standard protocols as well as expertise in state of
the art techniques for diagnosis of neuropathological specimens.

Budget (Neuropathology Core)

Budget forms appropriate for the specific component
will be included in the application package.

Note:
The R&R Budget form included in many of the component types allows for up
to 100 Senior/Key Persons in section A and 100 Equipment Items in section C
prior to using attachments for additional entries. All other SF424 (R&R)
instructions apply.

A detailed composite budget (across all subprojects
and cores) for all requested support categories for the proposed award period
will be system-generated based on budget period data. If applicable, use SF424 R&R
Subaward Budget Attachment Forms for consortium/contractual arrangements.
Provide one budget for each consortium grantee. If more than 30 subawardees,
then include details for additional subawardees in budget justification
(Section K). Any questions about budget development may be directed to the
Financial and Grants Management Contact at the address below (Section VII).

All ADRC applications should request and provide
justification for five years of support in a single document in Section K of SF424
R&R Budget Form. The direct costs may be apportioned across cores and
pilots at the PD/PI discretion in order to best serve the unique needs of the
center. If large items of equipment are requested, the application must
document what is already available and provide clear justification in terms of
use by core staff and how it relates to research projects dependent on the
core. General-purpose equipment needs should be included and justified
only after surveying the availability of such items within the institution. See
Section C of SF424 R&R Budget Form.

Research patient care costs (both inpatient and
outpatient expenses) will be considered in the context of other existing
institutional clinical resources. Attempts should be made by the applicant
institution to utilize existing clinical facilities. Costs relating to
the clinical efforts of the ADRC may be funded through the ADRC, provided there
is no overlap of funding. Only those research patient costs directly related to
ADRC activities may be charged to the ADRC. See Special Instructions for
Patient Care Costs in SF424 (R&R) Application Guide.

Domestic and foreign travel of project personnel
directly related to the core and scientific activities of the ADRC is
allowable. Budgeting should include travel and lodging for 1) the
semi-annual meetings of the Center Directors, 2) annual meetings of
administrators, clinical core leaders, education core leaders, data managers,
and neuropathology core leaders and, 3) representatives of the Center to attend
ad hoc meetings called by the ADCs or the NIA to discuss research findings and
plan cooperative projects, to promulgate data sharing, and to discuss
standardization of procedures among the ADCs. See Section D of SF424 R&R
Budget Form.

PHS 398 Research Plan (Neuropathology
Core)

A core is a shared central laboratory or clinical
research facility, service, or resource whose function is essential to the
scientific purpose of the ADC. Each core is directed by an investigator
with substantial expertise related to the core. Facilities may be proposed that
will enhance productivity or in other ways benefit a group of investigators to
accomplish stated goals. Several important and related
considerations are (1) the degree to which currently funded investigators
within or outside the Center will use and will benefit from core resources, (2)
the degree to which the cores coordinate with each other to further the overall
Center mission and (3) the degree to which the resources will promote new
and/or expanded AD research efforts locally, regionally or nationally. Applicants
should document and describe briefly the research, both existing and planned,
whether funded by the Center or not, that has, or will depend upon, resources
provided by the requested cores.

Specific
Aims: Clearly state how the core will contribute to the goals
of the ADC and outline interactions of the core with each of the other cores
(and projects, if relevant) of the center.

Describe the state of the art diagnostic services,
strategy for collecting well-prepared brain material, and distribution of samples
for cutting edge research, locally as well as in cooperative research across
Centers and with other researchers outside of Centers

Research
Strategy: Organize the Research Strategy into sections on:
Significance, Innovation and Approach.

Significance: The neuropathology core has the responsibility for providing post mortem
diagnosis on cases and normal control subjects enrolled in the clinical core
and on other well documented AD cases and controls. Explain the role of the
Neuropathology core in the center as a whole and as a resource for other
ongoing activities in Alzheimer’s disease and other neurodegenerative
diseases.

Approach:

Progress Report (Revision Applications only): Clearly
summarize resource use in affiliated research projects and the new insights
obtained from these studies, as well as type and quantity of tissue provided to
investigators both funded by the Center and by other means. Describe the most
important contributions to research on AD, related dementias and aging utilizing
core resources. Reports should include Core objectives and progress in
meeting them. Basic functions of the cores should be briefly summarized.
Any developmental work carried out by the core should also be presented.
Publications resulting from resources or developmental work carried out by the
core should be listed.

New applications should describe preliminary
organizational work, experience with AD and other neurodegenerative disease
research, potential for developing new and exciting research, and specific
plans for implementation of the new program.

Procedures should be described related to criteria
for diagnosis, and the collection, storage, and distribution of brain tissue
and other biological samples, including, but not limited to, cell lines,
cerebrospinal fluid (CSF) and plasma. Specimen collection, data gathering
and storage activities should be coordinated with those of the Clinical Core
and the Data Management Core. Describe how the core will provide a
resource for research studies that include clinical-pathological correlations
across Centers. To do so, ADCs should agree to follow standardized
procedures whenever possible, so that cross-Center correlations are possible.
(New applicants may go to the NACC to get the most recent best practice
guidelines for biospecimens: https://www.alz.washington.edu/BiospecimenTaskForce.html).
Unless specific research questions require brains from late stage AD patients,
emphasis should be placed on collection of normal, MCI and early AD brains, in
order to support specific research efforts of investigators affiliated with the
local center and other scientists. If collection of special material is
proposed (e.g., tissues from patients with other dementias) justification
should be included. If proposing developmental work, describe the role of this
work and its significance to the core, the center and other research
activities.

To facilitate data sharing and cross-Center
comparisons of diagnosis, all Centers should use the neuropathological criteria
for AD developed by the NIA-Alzheimer's Association Working Group (Acta
Neuropathol (2012) 123:1-11). If tissue from other diseases is collected, list
the clinical diagnostic criteria used. More detailed criteria for local
research purposes should also be described. Pathology data should be
included in the data set transmitted to NACC as defined by the UDS. (New
applicants may get information from NACC about the pathology data set).
Neuropathologists from the ADCs meet yearly to share ideas and discuss
technical aspects of tissue sampling, development of standardized tissue
processing for diverse research protocols, cataloging and data management, and
banking and distribution of tissues and biological samples. The applicant
should commit to sending a representative to this meeting.

Consortium/Contractual
Arrangements

For consortium arrangements, the application must
include the following information:

An explanation of the programmatic, fiscal, and administrative
arrangements made between the grantee institution and the collaborating
institutions.

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424
(R&R) Application Guide, with the following modifications:

Applicants should commit to cooperate fully and to share
specimens with other research scientists both within and outside the Centers
network as well as data concerning clinical core participants with the
NIA-sponsored National Alzheimer’s Coordinating Center (NACC) where uniform
data from all AD Centers is centrally stored. Any genetic specimens collected
by the Center (blood samples and DNA) should be made available to the National
Cell Repository for Alzheimer’s Disease (NCRAD), if they meet the criteria for
inclusion in the repository, in accordance with agreed upon protocols and
policies. Centers may also be requested to contribute other biological
samples such as serum and cerebrospinal fluid, using agreed upon protocols, for
trans-center studies examining biomarkers that might relate to risk, diagnosis
or progression of AD. Therefore, consent forms should be written to allow
for this possibility as well as for the possibility of eventual data sharing
with the wider research community, while maintaining participants’
confidentiality. The Steering Committee of the NACC in conjunction with the ADC
Directors and the NIA sets policies that allow the individual Centers to
conduct research on patients and control subjects collected by the individual
Center while also sharing common data sets with NACC. Applicants should follow
NIA and NIH policies on data and sample sharing (please see the following web
pages for further information, including example language that may be used in
consent forms:

Facilities
and Other Resources: Provide a description of all resources for
this core in the Facilities and Other Resources attachment. The information
will be used to evaluate the quality of the environment for this specific core.

In the Project Director/Principal Investigator section, use
Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA
Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list Senior/Key
persons that are working in the component.

Include a single Biographical Sketch for each Senior/Key person
listed in the application regardless of the number of components in which they
participate. When a Senior/Key person is listed in multiple components, the
Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component,
the Additional Senior Key Person attachments should be used.

ASSIST only allows a single biosketch for each person. Therefore
the biosketches must be comprehensive, covering multiple roles if a single
individual has multiple roles.

Core Project Leads should have demonstrated leadership and
administrative skills. Specifically, the Core Project Lead should be able to
organize and administer the resources created by the core or project in such a
way that they may be shared within the ADRC as well as with other interested
scientists. Demonstrated leadership in training young investigators is
desirable. The PD/PI of the ADRC may be a Core Project Lead, but sufficient
time must be devoted to the core or project to ensure that the aims are met and
required functions are carried out efficiently.

The Core Project Lead should have expertise in the primary area
of focus of the education core, either recruitment/outreach or professional
education/training, or both.

Budget (Outreach, Recruitment and
Education Core)

Budget forms appropriate for the specific component
will be included in the application package.

Note:
The R&R Budget form included in many of the component types allows for up
to 100 Senior/Key Persons in section A and 100 Equipment Items in section C
prior to using attachments for additional entries. All other SF424 (R&R)
instructions apply.

A detailed composite budget (across all subprojects
and cores) for all requested support categories for the proposed award period
will be system-generated based on budget period data. If applicable, use SF424 R&R
Subaward Budget Attachment Forms for consortium/contractual arrangements.
Provide one budget for each consortium grantee. If more than 30 subawardees,
then include details for additional subawardees in budget justification
(Section K). Any questions about budget development may be directed to the
Financial and Grants Management Contact at the address below (Section VII).

All ADRC applications should request and provide
justification for five years of support in a single document in Section K of SF424
R&R Budget Form. The direct costs may be apportioned across cores and
pilots at the PD/PI discretion in order to best serve the unique needs of the
center. If large items of equipment are requested, the application must
document what is already available and provide clear justification in terms of
use by core staff and how it relates to research projects dependent on the
core. General-purpose equipment needs should be included and justified
only after surveying the availability of such items within the institution. See
Section C of SF424 R&R Budget Form.

Research patient care costs (both inpatient and
outpatient expenses) will be considered in the context of other existing
institutional clinical resources. Attempts should be made by the applicant
institution to utilize existing clinical facilities. Costs relating to
the clinical efforts of the ADRC may be funded through the ADRC, provided there
is no overlap of funding. Only those research patient costs directly related to
ADRC activities may be charged to the ADRC. See Special Instructions for
Patient Care Costs in SF424 (R&R) Application Guide.

Domestic and foreign travel of project personnel
directly related to the core and scientific activities of the ADRC is
allowable. Budgeting should include travel and lodging for 1) the
semi-annual meetings of the Center Directors, 2) annual meetings of
administrators, clinical core leaders, education core leaders, data managers,
and neuropathology core leaders and, 3) representatives of the Center to attend
ad hoc meetings called by the ADCs or the NIA to discuss research findings and
plan cooperative projects, to promulgate data sharing, and to discuss
standardization of procedures among the ADCs. See Section D of SF424 R&R
Budget Form.

PHS 398 Research Plan (Outreach,
Recruitment and Education Core)

A core is a shared central laboratory or clinical
research facility, service, or resource whose function is essential to the
scientific purpose of the ADC. Each core is directed by an investigator
with substantial expertise related to the core. Facilities may be proposed that
will enhance productivity or in other ways benefit a group of investigators to
accomplish stated goals. Several important and related
considerations are (1) the degree to which currently funded investigators
within or outside the Center will use and will benefit from core resources, (2)
the degree to which the cores coordinate with each other to further the overall
Center mission and (3) the degree to which the resources will promote new
and/or expanded AD research efforts locally, regionally or nationally.
Applicants should document and describe briefly the research, both existing and
planned, whether funded by the Center or not, that has, or will depend upon,
resources provided by the requested cores.

Specific
Aims: Clearly state how the core will contribute to the goals
of the ADC and outline interactions of the core with each of the other cores
(and projects, if relevant) of the center.

Summarize the outreach and education needs of the
center as well as local academic and community settings. Outline recruitment
plans in light of the needs of the research that will rely on the center.
Provide an overview of any professional development activities.

Research
Strategy: Organize the Research Strategy into sections on:
Significance, Innovation and Approach.

Significance: The Outreach core has the responsibility for providing important liaison and outreach
between the ADC and patients, their caregivers and the professional community
so that information may be communicated bidirectionally. Explain the role of
the education core in the center as a whole and as a community resource on
Alzheimer’s Disease.

Approach:

Progress Report (Renewal Applications only): Describe
efforts to assist the clinical core and NIA special initiatives, such as the
genetics initiative, in subject recruitment, especially any efforts directed to
recruitment of minority and ethnically diverse subjects. Provide information
about training activities that effectively impart knowledge to professionals
and the lay public. Describe other outreach activities. Describe the most
important contributions to research on AD, related dementias and aging
utilizing core resources. Reports should include Core objectives and
progress in meeting them. Basic functions of the cores should be briefly
summarized. Any developmental work carried out by the core should also be
presented. Publications resulting from resources or developmental work carried
out by the core should be listed.

New applications should describe preliminary
organizational work, experience with AD and other neurodegenerative disease
research, potential for developing new and exciting research, and specific
plans for implementation of the new program.

Provide an assessment of the outreach and educational
needs that are unique to the center as well as to the geographical area in the
vicinity of the ADC, including identifying underserved groups. The assessment
might include information about census data, community organizations, and an
evaluation of the educational, outreach and recruitment activities and needs of
each research function of the center. Depending on the local needs as
identified in the analysis of local needs, the education core may focus either
on A) coordination with the clinical core for recruitment and retention of
subjects for particular research protocols and clinical trials, with a special
emphasis on underserved/underrepresented populations and/or B) innovative
development of professional staff (including nurses, social workers,
physicians, researchers, medical students, other professional carers, etc.) for
clinical and research skills related to AD and other dementias. An outreach
plan should address the needs identified, including both strengths and barriers
(e.g., parking/transportation).

The methods and techniques to be employed to disseminate
information and the audience targeted to receive information should be defined
including 1) approaches to training of professionals including possible
reciprocal exchange programs between Centers to provide access to different
research environments and technologies; 2) descriptions of seminar or lecture
series, workshops and continuing education programs; 3) outreach to specific
communities to publicize research; 4) collaboration with other organizations
such as state and local agencies, the Alzheimer’s Association, other
community/service groups, sports teams, hospitals, religious organizations,
business groups, local medical societies, etc.) and 5) descriptions of
materials (e.g., videos and printed matter) to be developed by the Center.

Attention should be directed to issues of cultural
sensitivity and, where appropriate, the information should be structured so
that it can effectively reach diverse populations, including
non-English-speaking people. Procedures by which the education and outreach
activities are closely coordinated with the clinical core and satellite(s) (if
appropriate) should be described, especially in recruitment of diverse
populations. The education and outreach activities should also be prepared to
support activities of the Centers group as a whole as well as recruitment for
special NIA initiatives, such as subjects for genetic studies. Collaboration
with other ADCs and the NIA Alzheimer’s Disease Education and Referral Center
(ADEAR) in subject recruitment, education and coordinated dissemination of
educational materials is expected. Collaboration and/or consultation with
RCMARs regarding recruitment and retention of diverse elder populations are
encouraged (http://www.rcmar.ucla.edu/).

Other major activities of the Outreach Core might
include:

Create
and maintain community advisory groups.

Facilitate
junior investigator mentorship program development.

Evaluate
the outreach and professional training programs which may include, e.g., number
of participants, feedback forms, number of participants who sign up to receive
information or be contacted by the center, etc.

Communicate
the latest research findings both locally and generally to study participants,
families and professionals. These efforts might include website maintenance,
newsletters, brochures, seminars, workshops, media appearances, including TV,
radio and print.

Develop
and maintain a local registry/database of potential study volunteers – with and
without cognitive impairment, regardless of how well-characterized. Recruitment
may be coordinated with the Alzheimer’s Disease Cooperative Study group if the
center serves as a performance site.

Consortium/Contractual
Arrangements

For consortium arrangements, the application must
include the following information:

An explanation of the programmatic, fiscal, and administrative
arrangements made between the grantee institution and the collaborating
institutions.

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424
(R&R) Application Guide, with the following modifications:

Applicants should commit to cooperate fully and to share
specimens with other research scientists both within and outside the Centers
network as well as data concerning clinical core participants with the
NIA-sponsored National Alzheimer’s Coordinating Center (NACC) where uniform
data from all AD Centers is centrally stored. Any genetic specimens collected
by the Center (blood samples and DNA) should be made available to the National
Cell Repository for Alzheimer’s Disease (NCRAD), if they meet the criteria for inclusion
in the repository, in accordance with agreed upon protocols and policies.
Centers may also be requested to contribute other biological samples such as
serum and cerebrospinal fluid, using agreed upon protocols, for trans-center
studies examining biomarkers that might relate to risk, diagnosis or
progression of AD. Therefore, consent forms should be written to allow
for this possibility as well as for the possibility of eventual data sharing
with the wider research community, while maintaining participants’
confidentiality. The Steering Committee of the NACC in conjunction with the ADC
Directors and the NIA sets policies that allow the individual Centers to
conduct research on patients and control subjects collected by the individual
Center while also sharing common data sets with NACC. Applicants should follow
NIA and NIH policies on data and sample sharing (please see the following web
pages for further information, including example language that may be used in
consent forms:

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for
the Appendix as described in the SF424 (R&R) Application Guide.

Satellite Diagnostic and Treatment Clinic Core

When preparing your application in ASSIST, use Component
Type ‘Core.’

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions, as noted.

Satellite Diagnostic and Treatment Clinics (SDTCs) are
designed to increase the heterogeneity of the research patient pool and to
enhance the research capabilities of the ADC by extending the activities of the
clinical core. Existing Centers should retain any satellites or any
special recruitment activities within the clinical and education cores
previously designated as a satellite and should describe these activities in a
separate section of the application labeled as a separate core. New
satellite clinics may be proposed if they fit within the overall budget
requirements. Satellite clinics are not required to conduct research but
should serve as vehicles for the recruitment, diagnosis and management of AD
patients and control subjects from rural and minority communities, who are then
offered the opportunity to participate in research protocols, clinical drug
trials and autopsy. Effective satellites usually include multicultural
staff members who have links to the community being involved. In
addition, the satellite should have clearly delineated interactions with all of
the other cores of the center. Satellite facilities and associated
community resources may be described briefly in the clinical core section of
the application under Human Subjects, and details may be provided in the
section on resources in the Facilities & Other Resources attachment of the
Other Project Information form.

SF424 (R&R) Cover (Satellite
Diagnostic and Treatment Clinic Core)

Complete only the following fields:

Applicant
Information

Type of
Applicant (optional)

Descriptive
Title of Applicant’s Project (Note: If applicable, project title is Core F:
Satellite Diagnostic and Treatment Clinic Core)

Facilities
and Other Resource: Provide a description of all resources for
this core in the Facilities and Other Resources attachment. The information
will be used to evaluate the quality of the environment for this specific core.

In the Project Director/Principal Investigator section, use
Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA
Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list Senior/Key
persons that are working in the component.

Include a single Biographical Sketch for each Senior/Key person
listed in the application regardless of the number of components in which they
participate. When a Senior/Key person is listed in multiple components, the
Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component,
the Additional Senior Key Person attachments should be used.

ASSIST only allows a single biosketch for each person. Therefore
the biosketches must be comprehensive, covering multiple roles if a single
individual has multiple roles.

Core Project Leads should have demonstrated leadership and
administrative skills. Specifically, the Core Project Lead should be able to
organize and administer the resources created by the core or project in such a
way that they may be shared within the ADRC as well as with other interested
scientists. Demonstrated leadership in training young investigators is
desirable. The PD/PI of the ADRC may be a Core Project Lead, but sufficient
time must be devoted to the core or project to ensure that the aims are met and
required functions are carried out efficiently.

The Core Project Lead is often a neurologist, but may be a
neuropsychologist, psychiatrist, geriatrician or other clinician with expertise
in diagnosing Alzheimer’s and other neurodegenerative diseases. The Clinical
Core Project Lead should have a track record of research in some aspect of
neurodegenerative disease, preferably including interactions with key personnel
from other cores

Budget (Satellite Diagnostic and
Treatment Clinic Core)

Budget forms appropriate for the specific component
will be included in the application package.

Note:
The R&R Budget form included in many of the component types allows for up
to 100 Senior/Key Persons in section A and 100 Equipment Items in section C
prior to using attachments for additional entries. All other SF424 (R&R)
instructions apply.

A detailed composite budget (across all subprojects
and cores) for all requested support categories for the proposed award period
will be system-generated based on budget period data. If applicable, use SF424 R&R
Subaward Budget Attachment Forms for consortium/contractual arrangements.
Provide one budget for each consortium grantee. If more than 30 subawardees,
then include details for additional subawardees in budget justification
(Section K). Any questions about budget development may be directed to the
Financial and Grants Management Contact at the address below (Section VII).

All ADRC applications should request and provide
justification for five years of support in a single document in Section K of SF424
R&R Budget Form. The direct costs may be apportioned across cores and
pilots at the PD/PI discretion in order to best serve the unique needs of the
center. If large items of equipment are requested, the application must
document what is already available and provide clear justification in terms of
use by core staff and how it relates to research projects dependent on the
core. General-purpose equipment needs should be included and justified
only after surveying the availability of such items within the institution. See
Section C of SF424 R&R Budget Form.

Research patient care costs (both inpatient and
outpatient expenses) will be considered in the context of other existing
institutional clinical resources. Attempts should be made by the applicant
institution to utilize existing clinical facilities. Costs relating to
the clinical efforts of the ADRC may be funded through the ADRC, provided there
is no overlap of funding. Only those research patient costs directly related to
ADRC activities may be charged to the ADRC. See Special Instructions for
Patient Care Costs in SF424 (R&R) Application Guide.

Domestic and foreign travel of project personnel
directly related to the core and scientific activities of the ADRC is
allowable. Budgeting should include travel and lodging for 1) the
semi-annual meetings of the Center Directors, 2) annual meetings of
administrators, clinical core leaders, education core leaders, data managers,
and neuropathology core leaders and, 3) representatives of the Center to attend
ad hoc meetings called by the ADCs or the NIA to discuss research findings and
plan cooperative projects, to promulgate data sharing, and to discuss
standardization of procedures among the ADCs. See Section D of SF424 R&R
Budget Form.

If an optional satellite core is included, it should
have a separate budget in a core component specific to the satellite core. If
an existing satellite has been rolled into a clinical core, the budget for the
satellite must still be identifiable within the budget justification of the clinical
core budget.

A core is a shared central laboratory or clinical
research facility, service, or resource whose function is essential to the
scientific purpose of the ADC. Each core is directed by an investigator
with substantial expertise related to the core. Facilities may be proposed that
will enhance productivity or in other ways benefit a group of investigators to
accomplish stated goals. Several important and related
considerations are (1) the degree to which currently funded investigators
within or outside the Center will use and will benefit from core resources, (2)
the degree to which the cores coordinate with each other to further the overall
Center mission and (3) the degree to which the resources will promote new
and/or expanded AD research efforts locally, regionally or nationally.
Applicants should document and describe briefly the research, both existing and
planned, whether funded by the Center or not, that has, or will depend upon,
resources provided by the requested cores.

Specific
Aims: Clearly state how the core will contribute to the goals
of the ADC and outline interactions of the core with each of the other cores
(and projects, if relevant) of the center.

Research
Strategy: Organize the Research Strategy into sections on:
Significance, Innovation and Approach.

For Renewal Applications: Place Progress Reports in
the approach section of each core. Describe the most important contributions to
research on AD, related dementias and aging utilizing core resources. Reports
should include Core objectives and progress in meeting them. Basic
functions of the cores should be briefly summarized. Any developmental work
carried out by the core should also be presented. Publications resulting from
resources or developmental work carried out by the core should be listed.

New applications should describe preliminary
organizational work, experience with AD and other neurodegenerative disease
research, potential for developing new and exciting research, and specific
plans for implementation of the new program.

Consortium/Contractual
Arrangements

For consortium arrangements, the application must
include the following information:

An explanation of the programmatic, fiscal, and
administrative arrangements made between the grantee institution and the
collaborating institutions.

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424
(R&R) Application Guide, with the following modifications:

Applicants should commit to cooperate fully and to share
specimens with other research scientists both within and outside the Centers
network as well as data concerning clinical core participants with the
NIA-sponsored National Alzheimer’s Coordinating Center (NACC) where uniform
data from all AD Centers is centrally stored. Any genetic specimens collected
by the Center (blood samples and DNA) should be made available to the National
Cell Repository for Alzheimer’s Disease (NCRAD), if they meet the criteria for
inclusion in the repository, in accordance with agreed upon protocols and
policies. Centers may also be requested to contribute other biological
samples such as serum and cerebrospinal fluid, using agreed upon protocols, for
trans-center studies examining biomarkers that might relate to risk, diagnosis
or progression of AD. Therefore, consent forms should be written to allow
for this possibility as well as for the possibility of eventual data sharing
with the wider research community, while maintaining participants’
confidentiality. The Steering Committee of the NACC in conjunction with the ADC
Directors and the NIA sets policies that allow the individual Centers to
conduct research on patients and control subjects collected by the individual
Center while also sharing common data sets with NACC. Applicants should follow
NIA and NIH policies on data and sample sharing (please see the following web
pages for further information, including example language that may be used in
consent forms:

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for
the Appendix as described in the SF424 (R&R) Application Guide.

Additional Cores

When preparing your application in ASSIST, use Component
Type ‘Core.’

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions, as noted.

The NIA will support additional cores that provide
opportunities for scientific research beyond those attainable solely through
support of the mandatory cores and other functions. However, any optional cores
must support one or more research projects and fit within the budget
restrictions outlined in the budget guidelines for the application. Support
should not be requested for cores that only replace or centralize resources
supported on individual project grants. In a Center grant application, it is
not sufficient for the PD/PI merely to identify such centralized
resources. Rather, it must be demonstrated exactly how each core would
augment or enhance the present capabilities of investigators using center
resources to make possible new activities at the home Center as well as other
Centers. There should be a detailed discussion of the project(s) that
will use resources of additional cores.

Some examples of research support that core components could
provide are:

Facilities
and Other Resources: Provide a description of all resources for
this core in the Facilities and Other Resources attachment. The information
will be used to evaluate the quality of the environment for this specific core.

Project /Performance Site Location(s)
(Additional Cores)

List all performance sites that apply to the specific
component.

Note: The Project Performance Site form allows up to
300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key
Person Profile (Additional Cores)

In the Project Director/Principal Investigator section, use
Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA
Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list Senior/Key
persons that are working in the component.

Include a single Biographical Sketch for each Senior/Key person
listed in the application regardless of the number of components in which they
participate. When a Senior/Key person is listed in multiple components, the
Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component,
the Additional Senior Key Person attachments should be used.

ASSIST only allows a single biosketch for each person. Therefore
the biosketches must be comprehensive, covering multiple roles if a single
individual has multiple roles.

Core Project Leads should have demonstrated leadership and
administrative skills. Specifically, the Core Project Lead should be able to
organize and administer the resources created by the core or project in such a
way that they may be shared within the ADRC as well as with other interested
scientists. Demonstrated leadership in training young investigators is
desirable. The PD/PI of the ADRC may be a Core Project Lead, but sufficient
time must be devoted to the core or project to ensure that the aims are met and
required functions are carried out efficiently.

Budget (Additional Cores)

Budget forms appropriate for the specific component
will be included in the application package.

Note:
The R&R Budget form included in many of the component types allows for up
to 100 Senior/Key Persons in section A and 100 Equipment Items in section C
prior to using attachments for additional entries. All other SF424 (R&R)
instructions apply.

A detailed composite budget (across all subprojects
and cores) for all requested support categories for the proposed award period
will be system-generated based on budget period data. If applicable, use SF424 R&R
Subaward Budget Attachment Forms for consortium/contractual arrangements.
Provide one budget for each consortium grantee. If more than 30 subawardees,
then include details for additional subawardees in budget justification
(Section K). Any questions about budget development may be directed to the
Financial and Grants Management Contact at the address below (Section VII).

All ADRC applications should request and provide
justification for five years of support in a single document in Section K of SF424
R&R Budget Form. The direct costs may be apportioned across cores and
pilots at the PD/PI discretion in order to best serve the unique needs of the
center. If large items of equipment are requested, the application must document
what is already available and provide clear justification in terms of use by
core staff and how it relates to research projects dependent on the core.
General-purpose equipment needs should be included and justified only after
surveying the availability of such items within the institution. See Section C
of SF424 R&R Budget Form.

Research patient care costs (both inpatient and
outpatient expenses) will be considered in the context of other existing
institutional clinical resources. Attempts should be made by the applicant
institution to utilize existing clinical facilities. Costs relating to
the clinical efforts of the ADRC may be funded through the ADRC, provided there
is no overlap of funding. Only those research patient costs directly related to
ADRC activities may be charged to the ADRC. See Special Instructions for
Patient Care Costs in SF424 (R&R) Application Guide.

Domestic and foreign travel of project personnel
directly related to the core and scientific activities of the ADRC is allowable.
Budgeting should include travel and lodging for 1) the semi-annual meetings of
the Center Directors, 2) annual meetings of administrators, clinical core
leaders, education core leaders, data managers, and neuropathology core leaders
and, 3) representatives of the Center to attend ad hoc meetings called by the
ADCs or the NIA to discuss research findings and plan cooperative projects, to
promulgate data sharing, and to discuss standardization of procedures among the
ADCs. See Section D of SF424 R&R Budget Form.

PHS 398 Research Plan (Additional
Cores)

A core is a shared central laboratory or clinical
research facility, service, or resource whose function is essential to the
scientific purpose of the ADC. Each core is directed by an investigator
with substantial expertise related to the core. Facilities may be proposed that
will enhance productivity or in other ways benefit a group of investigators to
accomplish stated goals. Several important and related
considerations are (1) the degree to which currently funded investigators
within or outside the Center will use and will benefit from core resources, (2)
the degree to which the cores coordinate with each other to further the overall
Center mission and (3) the degree to which the resources will promote new
and/or expanded AD research efforts locally, regionally or nationally.
Applicants should document and describe briefly the research, both existing and
planned, whether funded by the Center or not, that has, or will depend upon,
resources provided by the requested cores.

Additional cores may be proposed but only if they are
needed to advance the local research effort and if they fit within the budget
limits described elsewhere in this FOA.

Specific
Aims: Clearly state how the core will contribute to the goals
of the ADC and outline interactions of the core with each of the other cores
(and projects, if relevant) of the center.

Demonstrate the augmentation or enhancement of
capabilities of center resources to make possible new activities at the applicant
center as well as other centers. Provide a description of research project(s)
that will use resources of the additional core(s).

Research
Strategy: Organize the Research Strategy into sections on:
Significance, Innovation and Approach.

For Renewal Applications: Place Progress Reports in
the approach section of each core. Describe the most important contributions to
research on AD, related dementias and aging utilizing core resources.
Reports should include Core objectives and progress in meeting them.
Basic functions of the cores should be briefly summarized. Any developmental
work carried out by the core should also be presented. Publications resulting
from resources or developmental work carried out by the core should be
listed.

New applications should describe preliminary
organizational work, experience with AD and other neurodegenerative disease
research, potential for developing new and exciting research, and specific
plans for implementation of the new program.

Consortium/Contractual
Arrangements

For consortium arrangements, the application must
include the following information:

An explanation of the programmatic, fiscal, and administrative
arrangements made between the grantee institution and the collaborating
institutions.

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424
(R&R) Application Guide, with the following modifications:

Applicants should commit to cooperate fully and to share
specimens with other research scientists both within and outside the Centers
network as well as data concerning clinical core participants with the
NIA-sponsored National Alzheimer’s Coordinating Center (NACC) where uniform
data from all AD Centers is centrally stored. Any genetic specimens collected
by the Center (blood samples and DNA) should be made available to the National
Cell Repository for Alzheimer’s Disease (NCRAD), if they meet the criteria for
inclusion in the repository, in accordance with agreed upon protocols and
policies. Centers may also be requested to contribute other biological
samples such as serum and cerebrospinal fluid, using agreed upon protocols, for
trans-center studies examining biomarkers that might relate to risk, diagnosis
or progression of AD. Therefore, consent forms should be written to allow
for this possibility as well as for the possibility of eventual data sharing
with the wider research community, while maintaining participants’
confidentiality. The Steering Committee of the NACC in conjunction with the ADC
Directors and the NIA sets policies that allow the individual Centers to
conduct research on patients and control subjects collected by the individual
Center while also sharing common data sets with NACC. Applicants should follow
NIA and NIH policies on data and sample sharing (please see the following web
pages for further information, including example language that may be used in
consent forms:

Facilities
and Other Resources: Provide a description of all resources for
each proposed project in the Facilities and Other Resources attachment. The
information will be used to evaluate the quality of the environment for each
project.

Project /Performance Site Location(s)
(Research Projects)

List all performance sites that apply to the specific
component.

Note: The Project Performance Site form allows up to
300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key
Person Profile (Research Projects)

In the Project Director/Principal Investigator section, use
Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA
Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list Senior/Key
persons that are working in the component.

Include a single Biographical Sketch for each Senior/Key person
listed in the application regardless of the number of components in which they
participate. When a Senior/Key person is listed in multiple components, the
Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component,
the Additional Senior Key Person attachments should be used.

ASSIST only allows a single biosketch for each person. Therefore
the biosketches must be comprehensive, covering multiple roles if a single individual
has multiple roles.

Core Project Leads should have demonstrated leadership and
administrative skills. Specifically, the Core Project Lead should be able to
organize and administer the resources created by the core or project in such a
way that they may be shared within the ADRC as well as with other interested
scientists. Demonstrated leadership in training young investigators is
desirable. The PD/PI of the ADRC may be a Core Project Lead, but sufficient
time must be devoted to the core or project to ensure that the aims are met and
required functions are carried out efficiently.

Budget (Research Projects)

Budget forms appropriate for the specific component
will be included in the application package.

Note:
The R&R Budget form included in many of the component types allows for up
to 100 Senior/Key Persons in section A and 100 Equipment Items in section C
prior to using attachments for additional entries. All other SF424 (R&R)
instructions apply.

A detailed composite budget (across all subprojects
and cores) for all requested support categories for the proposed award period
will be system-generated based on budget period data. If applicable, use SF424 R&R
Subaward Budget Attachment Forms for consortium/contractual arrangements.
Provide one budget for each consortium grantee. If more than 30 subawardees,
then include details for additional subawardees in budget justification
(Section K). Any questions about budget development may be directed to the
Financial and Grants Management Contact at the address below (Section VII).

All ADRC applications should request and provide
justification for five years of support in a single document in Section K of SF424
R&R Budget Form. The direct costs may be apportioned across cores and
pilots at the PD/PI discretion in order to best serve the unique needs of the
center. If large items of equipment are requested, the application must
document what is already available and provide clear justification in terms of
use by core staff and how it relates to research projects dependent on the
core. General-purpose equipment needs should be included and justified
only after surveying the availability of such items within the institution. See
Section C of SF424 R&R Budget Form.

Research patient care costs (both inpatient and
outpatient expenses) will be considered in the context of other existing
institutional clinical resources. Attempts should be made by the applicant
institution to utilize existing clinical facilities. Costs relating to
the clinical efforts of the ADRC may be funded through the ADRC, provided there
is no overlap of funding. Only those research patient costs directly related to
ADRC activities may be charged to the ADRC. See Special Instructions for
Patient Care Costs in SF424 (R&R) Application Guide.

Domestic and foreign travel of project personnel
directly related to the core and scientific activities of the ADRC is
allowable. Budgeting should include travel and lodging for 1) the
semi-annual meetings of the Center Directors, 2) annual meetings of administrators,
clinical core leaders, education core leaders, data managers, and
neuropathology core leaders and, 3) representatives of the Center to attend ad
hoc meetings called by the ADCs or the NIA to discuss research findings and
plan cooperative projects, to promulgate data sharing, and to discuss
standardization of procedures among the ADCs. See Section D of SF424 R&R
Budget Form.

PHS 398 Research Plan (Research
Projects)

Research
Strategy: Organize the Research Strategy into sections on:
Significance, Innovation and Approach.

Applications should request funding for two or three
research projects (similar to small R01s). The research projects should
request up to five years of funding and propose studies that will advance our
understanding of the basic and clinical underpinnings of AD and related
disorders. Projects may focus on areas such as preclinical etiology, genetics,
pathogenesis, epidemiology, diagnosis, therapeutic interventions including
small scale clinical trials, patient management, and caregiver issues.
Projects that are translational, focusing on drug discovery or preclinical drug
development for AD or other neurodegenerative diseases are also encouraged.
These may focus on: validation of new therapeutic targets, development of new
assays or animal models, screening of candidate compounds or acquisition of
preliminary preclinical efficacy data. The projects should be similar in
quality to small R01 grants and subprojects of program project grants. It is
required that at least one of the projects predominantly utilizes patients or
patient samples from the clinical core or neuropathology resources. As
part of the mission of the Centers program is to train and encourage new
researchers in the field of AD, at least one of the projects should be led or
co-led by a junior investigator (to include post doctoral fellows and junior
faculty who have not yet had NIH R01 grant support) or someone new to the field
(whose primary publications and grants focus on an area other than AD) or
include plans for development of a junior investigator.

Consortium/Contractual
Arrangements

For consortium arrangements, the application must
include the following information:

An explanation of the programmatic, fiscal, and administrative
arrangements made between the grantee institution and the collaborating
institutions.

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424
(R&R) Application Guide, with the following modifications:

Applicants should commit to cooperate fully and to share
specimens with other research scientists both within and outside the Centers
network as well as data concerning clinical core participants with the
NIA-sponsored National Alzheimer’s Coordinating Center (NACC) where uniform
data from all AD Centers is centrally stored. Any genetic specimens collected
by the Center (blood samples and DNA) should be made available to the National
Cell Repository for Alzheimer’s Disease (NCRAD), if they meet the criteria for
inclusion in the repository, in accordance with agreed upon protocols and
policies. Centers may also be requested to contribute other biological
samples such as serum and cerebrospinal fluid, using agreed upon protocols, for
trans-center studies examining biomarkers that might relate to risk, diagnosis
or progression of AD. Therefore, consent forms should be written to allow
for this possibility as well as for the possibility of eventual data sharing
with the wider research community, while maintaining participants’
confidentiality. The Steering Committee of the NACC in conjunction with the ADC
Directors and the NIA sets policies that allow the individual Centers to
conduct research on patients and control subjects collected by the individual
Center while also sharing common data sets with NACC. Applicants should follow
NIA and NIH policies on data and sample sharing (please see the following web
pages for further information, including example language that may be used in
consent forms:

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for
the Appendix as described in the SF424 (R&R) Application Guide.

3. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications
before the deadline to ensure they have time to make any application
corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants
across all Federal agencies. Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration.

Applicants
are responsible for viewing their application before the deadline in the eRA
Commons to ensure accurate and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically.

Important
reminders:All PD(s)/PI(s) and component Project Leads must include their
eRA Commons ID in the Credential fieldof the Senior/Key Person Profile
Component of the SF424(R&R) Application Package. Failure to register
in the Commons and to include a valid PD/PI Commons ID in the credential field
will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the System for Award Management (SAM). Additional information
may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review and responsiveness by NIA, NIH. Applications that are
incomplete and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to
notify the NIA Referral Office by email at Vemuri@nia.nih.gov when the application has been submitted. Please include the FOA number and
title, PD/PI name, and title of the application.

Participation in ADC Meetings

In order to assure active collaboration with other Centers,
the ADRC PD/PI and other staff should attend semi-annual meetings of the ADC PD/PIs
and other ad hoc meetings arranged by the ADCs or the NIA to share research
findings, participate in planning for cooperative research or help to refine
and standardize operating procedures among the Centers..

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

For this particular announcement, note the following:

Overall
Impact-Overall

Reviewers will provide an overall impact/priority score to
reflect their assessment of the likelihood for the project to exert a
sustained, powerful influence on the research field(s) involved, in
consideration of the following five core review criteria, and additional review
criteria (as applicable for the project proposed).

Scored Review Criteria - Overall

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?

How strong is the base of ongoing high quality
research in AD and other related neurodegenerative disorders? Do the stated
goals and plans demonstrate potential for contributing to cutting edge research
on normal aging, MCI, early AD and related disorders? How well is the center able
to participate in coordinated national efforts for collaborative research (including
establishing network of investigators, sharing data and resources within the
network, and holding jointly organized meetings)?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other
researchers well suited to the project? If Early Stage Investigators or New
Investigators, or in the early stages of independent careers, do they have
appropriate experience and training? If established, have they demonstrated an
ongoing record of accomplishments that have advanced their field(s)? If the
project is collaborative or multi-PD/PI, do the investigators have
complementary and integrated expertise; are their leadership approach,
governance and organizational structure appropriate for the project?

How well do the investigators and staff provide
creative scientific and administrative leadership of the Center and demonstrate
a commitment to devote adequate time to the management of the ADRC program? Is
there evidence of collaboration and interdisciplinary research among the
investigators who will be associated with the ADRC? Does the group have
stability? Are plans for recruitment of new personnel addressed? Are transition
plans clearly described and feasible?

Innovation

Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed?

How well do the proposed center and each component demonstrate
the capacity to develop critical new knowledge and unique and innovative
contributions to AD research locally and nationally?

Approach

Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented?
If the project is in the early stages of development, will the strategy
establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?

How well does the proposed Center demonstrate
appropriate organization and core management? Are the organizational plan and
management structure adequate to meet Center goals and the requirements spelled
out in this FOA? Are the procedures for internal communication and cooperation
among the investigators adequate?

Environment

Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements?

How adequate are the relevant facilities for the
proposed work? Does the geographic relationship between facilities seem
reasonable to carry out the proposed work? How strong are the environment and
core resources to enhance cutting-edge research by bringing together
multidisciplinary investigators?

Additional Review Criteria - Overall

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact score, but will not give
separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their participation
according to the following five review criteria: 1) risk to subjects, 2)
adequacy of protection against risks, 3) potential benefits to the subjects and
others, 4) importance of the knowledge to be gained, and 5) data and safety
monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and
Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities
and members of both genders, as well as the inclusion of children. For
additional information on review of the Inclusion section, please refer to the Human
Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

For Renewals, the committee will consider the
progress made in the last funding period.

Revisions

Not Applicable

Additional Review Considerations - Overall

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these
items, and should not consider them in providing an overall impact score.

Applications from Foreign
Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

The adequacy of plans to share brain tissue and
biological specimens with other research scientists both within and outside the
AD Centers network will be assessed. Any specimens that could be used for
genetics research (e.g., blood, tissue) by the Center should be made available
to the National Cell Repository for Alzheimer's Disease (NCRAD), if they meet
the criteria for inclusion in the repository, in accordance with agreed upon
protocols and policies

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s), convened by the NIA, in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall impact
score.

Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in
response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds
with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second
level of review by the National Advisory Council on Aging. The following will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement
and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

The awardee institution will provide NIH with specific plans for
data and safety monitoring, and will notify the IRB and NIH of serious adverse
events and unanticipated problems, consistent with NIH DSMP
policies.

When multiple years are involved, awardees will be required
to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR)
annually and financial statements as required in the NIH
Grants Policy Statement.

A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH Grants
Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants
Policy Statement for additional information on this reporting
requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.